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ISO 13485 Lead Auditor Training

Certified Lead Auditor Training Course

Gain a thorough understanding of how to conduct effective audits of quality management systems for medical devices through expert instruction, engaging class discussions, and interactive workshops using ISO 13485:2016 as the primary audit criteria.

Over five rigorous days, go through every phase of an audit – from planning to conducting to following up – so you will be able to lead your own audits efficiently and effectively against the ISO 13485 standard.

Workshops reinforce key topics, including development of audit tools and checklists, opening and closing meetings, listening and questioning techniques, interpretation of auditor evidence, nonconformance reports, and audit documentation. Our approach teaches the audit discipline in accordance with ISO 19011 while providing a sector-focused learning experience for those engaged in the medical device industry.

Course Objectives

Over five rigorous days, discuss the background of the ISO 13485 and ISO 9001 standards and go through every phase of the audit – from planning to conducting to following up – so you will be able to lead your own audits efficiently and effectively.

Quality System Foundations – Understand the core concepts of an effective quality system, such as process and risk-based approaches.

The Requirements – Learn about the ISO 9000 standard series and the relationships among ISO 9001:2015, FDA’s Quality System Regulation, and ISO 13485:2016 requirements.

Audit Process – Understand the QMS registration process and the various types of audits along with auditor responsibilities in each.

Preaudit Activities – Learn how to plan all aspects of an audit.

Conducting the Audit – Learn how to collect objective evidence.

Postaudit and Follow-Up Activities – Learn how to present audit results and follow-up.

Course Topics

Interpretation and use of ISO 13485:2016

The audit cycle and ISO 19011

Audit planning activities

Process and risk-based auditing techniques

Interviewing and listening techniques

Evidence collection techniques and sampling

Nonconformity reporting

Audit follow-up and corrective action

Who Should Attend

Although originally designed to train third-party auditors, most participants lead their company’s quality system implementation and/or audit programs. Ideal for anybody involved in a supplier quality assurance program.

Exemplar Global-Certification

This training course is an Exemplar Global-certified course and meets the training requirements for certification of individual QMS Auditors, QMS Senior Auditors, and QMS Lead Auditors. "Successful completion" satisfies the training requirements for individual auditor certification by Exemplar Global.

To attain registration as a ISO 13485 QMS Auditor, QMS Senior Auditor, or QMS Lead Auditor, you must pass the written final examination, earn a passing grade in the course continuous assessments, and meet prescribed professional requirements, including a number of actual ISO 13485 audits.

Exemplar Global requires that all attendees study the current published version of ISO 13485 before attending.

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